Recruitment strategies and design considerations in a trial of resistance training to prevent dose-limiting toxicities in colon cancer patients undergoing chemotherapy.

Bette J Caan, Jeffrey A Meyerhardt, Justin C Brown, Kristin L Campbell, Elizabeth M Cespedes Feliciano, Catherine Lee, Michelle C Ross, Sara Quinney, Charles Quesenberry, Barbara Sternfeld, Kathryn H Schmitz

Journal: Contemporary clinical trials 2021;101():106242

PMID: 33301991

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Abstract

Low muscle is associated with an increased risk of chemotherapy-related dose limiting toxicities (DLT) in cancer patients. Resistance training (RT) improves muscle mass; however, the effects of RT on preventing DLTs and dose reductions in colon cancer patients has not been investigated. FOcus on Reducing dose-limiting toxicities in Colon cancer with resistance Exercise (FORCE) is a multicenter, randomized clinical trial examining the effects of RT on relative dose intensity (RDI; primary outcome) and moderate and severe chemotoxicities (primary outcome) in non-metastatic colon cancer patients receiving adjuvant chemotherapy. Patients (N = 180) will be recruited from Kaiser Permanente Northern California, Dana-Farber Cancer Institute, and Penn State Cancer Institute. This paper describes recruitment strategies and design considerations. Patients will be randomized in equal numbers to RT intervention or control. Patients have baseline and post completion of chemotherapy visits where information on anthropometry, physical function, body composition, quality of life, physical activity and dietary behaviors, and inflammatory blood markers will be collected. Patient-reported outcomes of chemotherapy side effects will be collected around the time of chemotherapy throughout the duration of the trial. Intervention participants will be prescribed a progressive RT program consisting of 4-6 visits with a certified exercise trainer, delivered either in-person or remotely by video conference, and will be asked to engage twice weekly in-home training sessions. Control patients at the end of the study receive a consult with a FORCE exercise trainer, an online exercise RT training program and a set of resistance bands. Results of this trial will provide information on the benefit of resistance exercise as a treatment to increase RDI.

Address: Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612, USA. Electronic address: [email protected].; Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, 450 Brookline Ave, Boston, MA 02215, USA. Electronic address: [email protected].; Cancer Metabolism Research Program, Pennington Biomedical Research Center, Louisiana State University, 6400 Perkins Road, Baton Rouge, Louisiana 70808, USA. Electronic address: [email protected].; Department of Physical Therapy, University of British Columbia, 212 Friedman Building, 2177 Westbrook Mall, Vancouver, British Columbia V6T 1Z3, Canada. Electronic address: [email protected].; Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612, USA. Electronic address: [email protected].; Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612, USA. Electronic address: [email protected].; Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612, USA. Electronic address: [email protected].; Disease and Therapeutic Response Modeling Program, Indiana University School of Medicine, 950 W Walnut Street, Indianapolis, Indiana 46202, USA. Electronic address: [email protected].; Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612, USA. Electronic address: [email protected].; Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612, USA.; Penn State Cancer Institute, The Pennsylvania State University, 500 University Drive, Hershey, PA 17033, USA. Electronic address: [email protected].

DOI: 10.1016/j.cct.2020.106242

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MeSH Terms: Chemotherapy, Adjuvant, Colonic Neoplasms, Exercise, Humans, Quality of Life, Resistance Training